SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form10-Q

 

xQUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended June 30,December 31, 2014

OR

 

¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                    to                    

Commission file number0-14902

MERIDIAN BIOSCIENCE, INC.

Incorporated under the laws of Ohio

31-0888197

(I.R.S. Employer Identification No.)

3471 River Hills Drive

Cincinnati, Ohio 45244

(513)271-3700

Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes  xþ            No   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes  xþ            No   ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   xþ  Accelerated filer ¨
Non-accelerated filer ¨  Smaller reporting company ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes  ¨            No   xþ

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class

 

Outstanding JulyJanuary 31, 20142015

Common Stock, no par value

 

41,567,521

41,705,940


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM10-Q

 

   Page(s) 

PART I.

FINANCIAL INFORMATION

  

Item 1.

Financial Statements (Unaudited)

  

Condensed Consolidated Statements of Operations Three and Nine Months Ended June 30,December 31, 2014 and 2013

   1  

Condensed Consolidated Statements of Comprehensive Income Three and Nine Months Ended June 30,December 31, 2014 and 2013

   2  

Condensed Consolidated Statements of Cash Flows NineThree Months Ended June 30,December 31, 2014 and 2013

   3  

Condensed Consolidated Balance Sheets June 30,December 31, 2014 and September 30, 20132014

   4-5  

Condensed Consolidated Statement of Changes in Shareholders’ Equity NineThree Months Ended June 30,December 31, 2014

   6  

Notes to Condensed Consolidated Financial Statements

   7-127-11  

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   12-2012-18  

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

   2119  

Item 4.

Controls and Procedures

   2119  

PART II.

OTHER INFORMATION

  

Item 1A.

Risk Factors

   2119  

Item 6.

Exhibits

   2119  

Signature

   2220  

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “should” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings and revenue, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. The CompanySpecifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following: Meridian’s continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, and its ability to effectively sell such products. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Meridian relies on proprietary, patented and licensed technologies, and the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result in


unanticipated expenses and delays and interruptions to the sale of new and existing products. The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict. One of Meridian’s growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses will be successfully integrated into Meridian’s operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. The CompanyMeridian cannot predict the possible impact of U.S. healthcarehealth care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the HealthcareHealth Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof, and any similar initiatives in other countries on its results of operations. Efforts to reduce the U.S. federal deficit, breaches of Meridian’s information technology systems and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and revenues. In addition to the factors described in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company.


PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except per share data)

 

  Three Months Ended 
  Three Months Ended
June 30,
 Nine Months Ended
June 30,
   December 31, 
  2014 2013 2014 2013   2014 2013 

NET REVENUES

  $47,212  $47,108  $142,140  $139,724   $48,013  $44,794 

COST OF SALES

   17,970  16,477  53,298  49,554    18,776  16,787 
  

 

  

 

  

 

  

 

   

 

  

 

 

GROSS PROFIT

   29,242   30,631   88,842   90,170    29,237   28,007 
  

 

  

 

  

 

  

 

   

 

  

 

 

OPERATING EXPENSES

        

Research and development

   3,146   2,711   9,185   8,039    3,103   2,853 

Selling and marketing

   6,249   5,440   18,787   16,604    6,080   5,978 

General and administrative

   6,715   6,781   20,446   21,484    7,385   7,550 
  

 

  

 

  

 

  

 

   

 

  

 

 

Total operating expenses

   16,110   14,932   48,418   46,127    16,568   16,381 
  

 

  

 

  

 

  

 

   

 

  

 

 

OPERATING INCOME

   13,132   15,699   40,424   44,043    12,669   11,626 

OTHER INCOME (EXPENSE)

        

Interest income

   5   12   15   38    6   4 

Other, net

   (257  (160  (505  225    (582  (220
  

 

  

 

  

 

  

 

   

 

  

 

 

Total other income (expense)

   (252  (148  (490  263    (576  (216
  

 

  

 

  

 

  

 

   

 

  

 

 

EARNINGS BEFORE INCOME TAXES

   12,880   15,551   39,934   44,306    12,093   11,410 

INCOME TAX PROVISION

   4,045   5,392   13,373   15,424    4,192   3,984 
  

 

  

 

  

 

  

 

   

 

  

 

 

NET EARNINGS

  $8,835  $10,159  $26,561  $28,882   $7,901  $7,426 
  

 

  

 

  

 

  

 

   

 

  

 

 

BASIC EARNINGS PER COMMON SHARE

  $0.21  $0.25  $0.64  $0.70   $0.19  $0.18 

DILUTED EARNINGS PER COMMON SHARE

  $0.21  $0.24  $0.63  $0.69   $0.19  $0.18 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

   41,478   41,304   41,445   41,209 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING—BASIC

   41,607   41,408 

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARES AND UNITS

   618   679   669   654    334   691 
  

 

  

 

  

 

  

 

   

 

  

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

   42,096   41,983   42,114   41,863 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING—DILUTED

   41,941   42,099 
  

 

  

 

  

 

  

 

   

 

  

 

 

ANTI-DILUTIVE SECURITIES:

        

Common share options and restricted shares and units

   337   256   161   295    566   110 
  

 

  

 

  

 

  

 

   

 

  

 

 

DIVIDENDS DECLARED PER COMMON SHARE

  $0.20  $0.19  $0.59  $0.57   $0.20  $0.19 
  

 

  

 

  

 

  

 

   

 

  

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 1


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Income (Unaudited)

(in thousands)

 

  Three Months Ended   Nine Months Ended   Three Months Ended 
  June 30,   June 30,   December 31, 
  2014   2013   2014   2013   2014 2013 

NET EARNINGS

  $8,835   $10,159   $26,561   $28,882   $7,901  $7,426 

Foreign currency translation adjustment

   361    154    1,421    (817   (1,365 723 
  

 

   

 

   

 

   

 

   

 

  

 

 

COMPREHENSIVE INCOME

  $9,196   $10,313   $27,982   $28,065   $6,536  $8,149 
  

 

   

 

   

 

   

 

   

 

  

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 2


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

Nine Months Ended June 30,

  2014 2013 

Three Months Ended December 31,

  2014 2013 

CASH FLOWS FROM OPERATING ACTIVITIES

      

Net earnings

  $26,561  $28,882   $7,901  $7,426 

Non-cash items included in net earnings:

      

Depreciation of property, plant and equipment

   2,634  2,522    927  888 

Amortization of intangible assets

   1,549  1,715    469  526 

Amortization of deferredillumigene instrument costs

   1,281  1,131    395  438 

Stock-based compensation

   2,662  1,984    1,428  1,651 

Deferred income taxes

   (438 (1,356   100  293 

Loss on disposition and write-down of fixed assets and other assets

   22  30 

Change in current assets

   (6,804 (3,125   4,878  1,600 

Change in current liabilities

   (4,055 951    246  (3,434

Other, net

   199  (220   (259 (43
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   23,611   32,514    16,085   9,345 
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

      

Purchases of property, plant and equipment

   (3,968  (2,193   (1,331  (899

Purchases of intangible assets

   (1,687  (20   —     (1,638
  

 

  

 

   

 

  

 

 

Net cash used for investing activities

   (5,655  (2,213   (1,331  (2,537
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

      

Dividends paid

   (24,464  (23,500   (8,330  (7,875

Proceeds and tax benefits from exercises of stock options

   629   2,094    499   407 
  

 

  

 

   

 

  

 

 

Net cash used for financing activities

   (23,835  (21,406   (7,831  (7,468
  

 

  

 

   

 

  

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

   882   (125   (454  107 
  

 

  

 

   

 

  

 

 

Net (Decrease) Increase in Cash and Equivalents

   (4,997  8,770 

Net Increase (Decrease) in Cash and Equivalents

   6,469   (553

Cash and Equivalents at Beginning of Period

   44,282   31,593    43,047   44,282 
  

 

  

 

   

 

  

 

 

Cash and Equivalents at End of Period

  $39,285  $40,363   $49,516  $43,729 
  

 

  

 

   

 

  

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 3


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(in thousands)

ASSETS

 

  December 31,   September 30, 
  June 30,
2014
   September 30,
2013
   2014   2014 
  (Unaudited)   

 

   (Unaudited)   

 

 

CURRENT ASSETS

        

Cash and equivalents

  $39,285   $44,282   $49,516   $43,047 

Accounts receivable, less allowances of $214 and $233

   25,806    26,183 

Accounts receivable, less allowances of $247 and $272

   23,613    23,232 

Inventories

   37,605    34,835    34,428    35,495 

Prepaid expenses and other current assets

   6,423    4,643    3,212    7,058 

Deferred income taxes

   4,331    4,145    3,890    3,916 
  

 

   

 

   

 

   

 

 

Total current assets

   113,450    114,088    114,659    112,748 
  

 

   

 

   

 

   

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

        

Land

   1,184    1,183    1,167    1,173 

Buildings and improvements

   26,930    26,848    29,251    29,146 

Machinery, equipment and furniture

   39,225    38,502    40,454    40,192 

Construction in progress

   2,982    554    1,185    652 
  

 

   

 

   

 

   

 

 

Subtotal

   70,321    67,087    72,057    71,163 

Less: accumulated depreciation and amortization

   43,014    40,996    44,137    43,553 
  

 

   

 

   

 

   

 

 

Net property, plant and equipment

   27,307    26,091    27,920    27,610 
  

 

   

 

   

 

   

 

 

OTHER ASSETS

        

Goodwill

   23,826    23,115    22,638    23,193 

Other intangible assets, net

   8,472    8,057    7,159    7,813 

Restricted cash

   1,000    1,000    1,000    1,000 

Deferredillumigene instrument costs, net

   2,982    3,270    2,477    2,740 

Deferred income taxes

   1,380    823    1,185    1,483 

Other assets

   346    304    400    342 
  

 

   

 

   

 

   

 

 

Total other assets

   38,006    36,569    34,859    36,571 
  

 

   

 

   

 

   

 

 

TOTAL ASSETS

  $178,763   $176,748   $177,438   $176,929 
  

 

   

 

   

 

   

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 4


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(dollars in thousands)

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

  December 31, September 30, 
  June 30,
2014
   September 30,
2013
   2014 2014 
  (Unaudited)   

 

   (Unaudited) 

 

 

CURRENT LIABILITIES

       

Accounts payable

  $6,416   $5,592   $5,941  $4,966 

Accrued employee compensation costs

   3,914    9,670    4,517  4,761 

Other accrued expenses

   5,738    5,462    3,018  3,149 

Income taxes payable

   875    979    1,073  859 
  

 

   

 

   

 

  

 

 

Total current liabilities

   16,943    21,703    14,549   13,735 
  

 

   

 

   

 

  

 

 

NON-CURRENT LIABILITIES

   2,043   2,165 

COMMITMENTS AND CONTINGENCIES

       

SHAREHOLDERS’ EQUITY

       

Preferred stock, no par value, 1,000,000 shares authorized, none issued

   —      —      —     —   

Common shares, no par value, 71,000,000 shares authorized, 41,564,271 and 41,517,839 shares issued, respectively

   —      —   

Common shares, no par value, 71,000,000 shares authorized, 41,700,686 and 41,622,216 shares issued, respectively

   —     —   

Additional paid-in capital

   110,669    107,412    113,462   111,851 

Retained earnings

   48,985    46,888    48,440   48,869 

Accumulated other comprehensive income

   2,166    745 

Accumulated other comprehensive income (loss)

   (1,056  309 
  

 

   

 

   

 

  

 

 

Total shareholders’ equity

   161,820    155,045    160,846   161,029 
  

 

   

 

   

 

  

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

  $178,763   $176,748   $177,438  $176,929 
  

 

   

 

   

 

  

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 5


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statement of Changes in Shareholders’ Equity (Unaudited)

(dollars and shares in thousands)

 

  Common
Shares
Issued
 Additional
Paid-In
Capital
   Retained
Earnings
 Accumulated
Other
Comprehensive
Income
   Total
Shareholders’
Equity
   Common
Shares
Issued
   Additional
Paid-In
Capital
   Retained
Earnings
 Accumulated
Other
Comprehensive
Income (Loss)
 Total
Shareholders’
Equity
 

Balance at September 30, 2013

   41,518  $107,412   $46,888  $745   $155,045 

Balance at September 30, 2014

   41,622   $111,851   $48,869  $309  $161,029 

Cash dividends paid

   —     —      (24,464  —      (24,464   —      —      (8,330  —    (8,330

Exercise of stock options

   44  595    —     —      595    53    183    —     —    183 

Conversion of restricted stock units

   3   —      —     —      —      26    —      —     —     —   

Cancellation of restricted shares

   (1  —      —     —      —   

Stock compensation expense

   —    2,662    —     —      2,662    —      1,428    —     —    1,428 

Net earnings

   —     —      26,561   —      26,561    —      —      7,901   —    7,901 

Foreign currency translation adjustment

   —     —      —    1,421    1,421    —      —      —    (1,365 (1,365
  

 

  

 

   

 

  

 

   

 

   

 

   

 

   

 

  

 

  

 

 

Balance at June 30, 2014

   41,564  $110,669   $48,985  $2,166   $161,820 

Balance at December 31, 2014

   41,701   $113,462   $48,440  $(1,056 $160,846 
  

 

  

 

   

 

  

 

   

 

   

 

   

 

   

 

  

 

  

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 6


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

Dollars in Thousands, Except Per Share Amounts

(Unaudited)

 

1.Basis of Presentation

The interim condensed consolidated financial statements are unaudited and are prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information, and the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. In the opinion of management,Management, the interim financial statements include all normal adjustments and disclosures necessary to present fairly the Company’s financial position as of June 30,December 31, 2014, the results of its operations for the three and nine month periods ended June 30,December 31, 2014 and 2013, and its cash flows for the ninethree month periods ended June 30,December 31, 2014 and 2013. These statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s fiscal 20132014 Annual Report on Form 10-K. Financial information as of September 30, 20132014 has been derived from the Company’s audited consolidated financial statements.

The results of operations for interim periods are not necessarily indicative of the results to be expected for the year.

 

2.Significant Accounting Policies

 

(a)Revenue Recognition and Accounts Receivable

Revenue is generally recognized from sales when product is shipped and title has passed to the customer. Revenue for the Diagnostics segment is reduced at the date of sale for product price adjustments due certain distributors under local contracts. Management estimates accruals for distributor price adjustments based on local contract terms, sales data provided by distributors, estimates of inventories of certain of our products held by distributors, historical statistics, current trends, and other factors. Changes to the accruals are recorded in the period that they become known. Such accruals were $4,074$4,950 at June 30,December 31, 2014 and $3,866$4,220 at September 30, 2013,2014, and have been netted against accounts receivable.

Revenue for our Diagnostics segment includes revenue for ourillumigene®molecular test system. This system includes an instrument, instrument accessories and test kits. In markets where the test system is sold via multiple deliverable arrangements, (i.e., the United States, Australia, Belgium, France, Holland and Italy), the cost of the instrument and instrument accessories areis deferred upon placement at a customer and amortized on a straight-line basis into cost of sales over the expected utilization period, generally three years.

We evaluate whether each deliverable in the arrangement is a separate unit of accounting. The significant deliverables are an instrument, instrument accessories (e.g., printer) and test kits. An instrument and instrument accessories are delivered to the customer prior to the start of the customer utilization period, in order to accommodate customer set-up and installation. There isde minimis consideration received from the customer at the time of instrument placement. We have determined that the instrument and instrument accessories are not a separate unit of accounting because such equipment can only be used to process and read the results from ourillumigene diagnostic tests (i.e., our instrument and test kits function together to deliver a diagnostic test result), and therefore the instrument and instrument accessories do not have standalone value to the customer. Consequently, there is no revenue allocated to the placement of the instrument and instrument accessories. Test kits are delivered to the customer over the utilization period of the instrument, which we estimate has a useful life of three years. Our average customer contract period, including estimated renewals, is at least equal to the estimated three-year utilization period. Revenue for the sale of test kits is recognized upon shipment and transfer of title to the customers.

 

Page 7


In markets where the test system is not sold via multiple deliverable arrangements, (i.e., countries other than the United States, Australia, Belgium, France, Holland and Italy), the cost of the instrument and instrument accessories is charged to cost of sales at the time of shipment and transfer of title to the customer. Revenue for the sales of instruments and instrument accessories and test kits is recognized upon shipment and transfer of title to the customers. In these markets, ourillumigenemolecular test system is sold to independent distributors who inventory the instruments, instrument accessories and test kits for resale to end-users.

Our products are generally not subject to a customer right of return except for product recall events under the rules and regulations of the Food and Drug Administration or equivalent agencies outside the United States. In this circumstance, the costs to replace affected products would be accrued at the time a loss was probable and estimable.

Life Science revenue for contract services may come from research and development services or manufacturing services, including process development work, or a combination of both. Revenue is recognized based on each of the deliverables in a given arrangement having distinct and separate customer pricing. Depending on the nature of the arrangement, revenue is recognized as services are performed and billed, upon completion and acceptance by the customer, or upon delivery of product and acceptance by the customer.

Trade accounts receivable are recorded in the accompanying Condensed Consolidated Balance Sheets at invoiced amounts less provisions for distributor price adjustments under local contracts and doubtful accounts. The allowance for doubtful accounts represents our estimate of probable credit losses and is based on historical write-off experience.experience and known conditions that would likely lead to non-payment. The allowance for doubtful accounts and related metrics, such as days’ sales outstanding, are reviewed monthly. Accounts with past due balances over 90 days are reviewed individually for collectibility. Customer invoices are charged off against the allowance when we believe it is probable that the invoices will not be paid.

 

(b)Comprehensive Income (Loss)

As reflected in the accompanying Condensed Consolidated Statements of Comprehensive Income, our comprehensive income or loss is comprised of net earnings and foreign currency translation.

Assets and liabilities of foreign operations are translated using period-end exchange rates with gains or losses resulting from translation included as a separate component of comprehensive income or loss. Revenues and expenses are translated using exchange rates prevailing during the period. We also recognize foreign currency transaction gains and losses on certain assets and liabilities that are denominated in the non-functional currencies.currencies of the Company or its subsidiaries. These gains and losses are included in other income and expense in the accompanying Condensed Consolidated Statements of Operations.

 

(c)Income Taxes

The provision for income taxes includes federal, foreign, state and local income taxes currently payable and those deferred because of temporary differences between income for financial reporting and income for tax purposes. We prepare estimates of permanent and temporary differences between income for financial reporting purposes and income for tax purposes. These differences are adjusted to actual upon filing of our tax returns, typically occurring in the third and fourth quarters of the current fiscal year for the preceding fiscal year’s estimates.

We account for uncertain tax positions using a benefit recognition model with a two-step approach: (i) a more-likely-than-not recognition criterion; and (ii) a measurement attribute that measures the position as the largest amount of tax benefit that is greater than 50% likely of being ultimately realized upon settlement. If it is not more likely than not that the benefit will be sustained on its technical merits, no benefit is recorded. We recognize accrued interest and penalties related to unrecognized tax benefits as a portion of our income tax provision in the Condensed Consolidated Statements of Operations.

In September 2013, the Internal Revenue Service issued Treasury Decision 9636, which enacted final tax regulations regarding the capitalization and expensing of amounts paid to acquire, produce, or improve tangible property. The regulations also include guidance regarding the retirement of depreciable property. The regulations are required to be effective in taxable years beginning on or after January 1, 2014, although

Page 8


taxpayers may choose to apply them in taxable years beginning on or after January 1, 2012. Our adoption of these regulations on October 1, 2014 isdid not expected to have a significant impact on the Company’s consolidated results of operations, cash flows or financial position.

 

Page 8


(d)Stock-based CompensationStock-Based Compensation

We recognize compensation expense for all share-based awards made to employees, based upon the fair value of the share-based award on the date of the grant. Awards are expensed over their requisite service periods.

 

(e)Cash and Cash Equivalents

Cash and cash equivalents include the following components:

 

  June 30, 2014   September 30, 2013   December 31, 2014   September 30, 2014 
  Cash and
Equivalents
   Other   Cash and
Equivalents
   Other   Cash and
Equivalents
   Other
Assets
   Cash and
Equivalents
   Other
Assets
 

Overnight repurchase agreements

  $24,074   $—     $32,103   $—     $31,881   $—     $26,407   $—   
        

Cash on hand -

        

Cash on hand—

        

Restricted

   —      1,000    —      1,000    —      1,000    —      1,000 

Unrestricted

   15,211    —      12,179    —      17,635    —      16,640    —   
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $39,285   $1,000   $44,282   $1,000   $49,516   $1,000   $43,047   $1,000 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

 

(f)Recent Accounting Pronouncements

In May 2014, FASBthe Financial Accounting Standards Board (“FASB”) issued ASUAccounting Standards Update (“ASU”) No. 2014-09,Revenue from Contracts with Customers,, which supersedes and replaces nearly all currently-existing U.S. GAAP revenue recognition guidance including related disclosure requirements. This guidance will be effective for the Company beginning October 1, 2017. The Company has not yet assessedcompleted its assessment of the impact that adoption of this guidance will have on its financial statements.

In November 2014, the FASB issued ASU No. 2014-17,Pushdown Accounting, which provides companies with the option to apply pushdown accounting in its separate financial statements upon occurrence of an event in which an acquirer obtains control of the acquired entity. The election to apply pushdown accounting can be made either in the period in which the change of control occurred or in a subsequent period. This guidance, which was effective as of November 18, 2014, has had no impact on the Company’s consolidated results of operations, cash flows or financial position.

Issued but not yet effective accounting pronouncements are not expected to have a material impact on the Condensed Consolidated Financial Statements.

 

(g)Reclassifications

Certain reclassifications have been made to the prior period financial statements to conform to the current fiscal period presentation. Such reclassifications had no impact on net earnings or shareholders’ equity.

 

Page 9


3.Inventories

Inventories are comprised of the following:

 

   June 30,
2014
   September 30,
2013
 

Raw materials

  $5,960   $7,170 

Work-in-process

   10,457    8,585 

Finished goods -illumigene instruments

   1,993    1,980 

Finished goods - kits and reagents

   19,195    17,100 
  

 

 

   

 

 

 

Total

  $37,605   $34,835 
  

 

 

   

 

 

 

   December 31,
2014
   September 30,
2014
 

Raw materials

  $7,060   $5,674 

Work-in-process

   9,770    10,591 

Finished goods—illumigene instruments

   1,459    1,710 

Finished goods—kits and reagents

   16,139    17,520 
  

 

 

   

 

 

 

Total

  $34,428   $35,495 
  

 

 

   

 

 

 

 

Page 9


4.Reportable Segment and Major Customers Information

Meridian was formed in 1976 and functions as a fully-integrated research, development, manufacturing, marketing and sales organization with primary emphasis in the fields of in vitro diagnostics and life science. Our principal businesses are (i) the development, manufacture and distribution of diagnostic test kits primarily for gastrointestinal, viral, respiratory and parasitic infectious diseases; and (ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic manufacturers, and the contract development and manufacture of proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

In the fourth quarter of fiscal 2013, we aggregated our Diagnostics operating segments into a single reportable segment, thereby resulting in ourOur reportable segments beingare Diagnostics and Life Science. The prior period information reflected herein has been conformed to the current period presentation.

The Diagnostics segment is headquartered in Cincinnati, Ohio, which also serves as the base of manufacturing operations and research and development. The Diagnostics segment has sales and distribution facilities in the United States, Europe and Australia. The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents domestically and abroad, including a sales and business development locationoffices in Singapore.Singapore and Beijing, China to further pursue growing revenue opportunities in Asia. The Life Science segment also includes the contract development and manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

Amounts due from two Diagnostics distributor customers accounted for 15%17% and 17%15% of consolidated accounts receivable at June 30,December 31, 2014 and September 30, 2013,2014, respectively. RevenueRevenues from these two distributor customers accounted for 36%41% and 40%38% of the Diagnostics segment third-party revenuerevenues during the three months ended June 30, 2014 and 2013, respectively, and 36% and 43% during the nine months ended June 30,December 31, 2014 and 2013, respectively. In addition, approximately $3,400$2,100 and $3,500$2,700 of our consolidated accounts receivable at June 30,December 31, 2014 and September 30, 2013,2014, respectively, iswas due from Italian hospital customers whose funding ultimately comes from the Italian government, representing 13%9% and 12% of consolidated accounts receivable in each of the respective periods.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 15%18% and 18%10% of the segment’s third-party revenuerevenues during the three months ended June 30, 2014 and 2013, respectively, and 16% and 18% during the nine months ended June 30,December 31, 2014 and 2013, respectively.

 

Page 10


Segment information for the interim periods is as follows:

 

   Diagnostics   Life
Science
   Eliminations(1)  Total 

Three Months Ended June 30, 2014

  

Net revenues -

       

Third-party

  $35,168   $12,044   $—    $47,212 

Inter-segment

   99    374    (473  —   

Operating income

   10,526    2,676    (70  13,132 

Goodwill (June 30, 2014)

   1,250    22,576    —     23,826 

Other intangible assets, net (June 30, 2014)

   2,853    5,619    —     8,472 

Total assets (June 30, 2014)

   111,208    68,200    (645  178,763 

Three Months Ended June 30, 2013

       

Net revenues -

       

Third-party

  $35,305   $11,803   $—    $47,108 

Inter-segment

   185    356    (541  —   

Operating income

   12,296    3,543    (140  15,699 

Goodwill (September 30, 2013)

   1,250    21,865    —     23,115 

Other intangible assets, net (September 30, 2013)

   1,561    6,496    —     8,057 

Total assets (September 30, 2013)

   111,719    65,393    (364  176,748 

Nine Months Ended June 30, 2014

       

Net revenues -

       

Third-party

  $107,066   $35,074   $—    $142,140 

Inter-segment

   362    858    (1,220  —   

Operating income

   32,211    8,243    (30  40,424 

Nine Months Ended June 30, 2013

       

Net revenues -

       

Third-party

  $107,377   $32,347   $—    $139,724 

Inter-segment

   388    864    (1,252  —   

Operating income

   36,130    8,223    (310  44,043 
   Diagnostics   Life Science   Eliminations(1)  Total 

Three Months Ended December 31, 2014

  

Net revenues—

       

Third-party

  $36,586   $11,427   $—    $48,013 

Inter-segment

   104    297    (401  —   

Operating income

   9,927    2,846    (104  12,669 

Goodwill (December 31, 2014)

   1,250    21,388    —     22,638 

Other intangible assets, net (December 31, 2014)

   2,649    4,510    —     7,159 

Total assets (December 31, 2014)

   110,922    66,892    (376  177,438 

Three Months Ended December 31, 2013

       

Net revenues—

       

Third-party

  $34,837   $9,957   $—    $44,794 

Inter-segment

   109    259    (368  —   

Operating income

   9,384    2,261    (19  11,626 

Goodwill (September 30, 2014)

   1,250    21,943    —     23,193 

Other intangible assets, net (September 30, 2014)

   2,756    5,057    —     7,813 

Total assets (September 30, 2014)

   109,350    67,834    (255  176,929 

 

(1)Eliminations consist of inter-segment transactions.

Transactions between segments are accounted for at established intercompany prices for internal and management purposes, with all intercompany amounts eliminated in consolidation.

 

Page 11


5.Intangible Assets

A summary of our acquired intangible assets subject to amortization, as of June 30,December 31, 2014 and September 30, 20132014 is as follows:

 

   June 30, 2014   September 30, 2013 
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $11,762   $10,512   $11,676   $10,097 

Trademarks, licenses and patents

   6,543    2,663    4,748    2,130 

Customer lists and supply agreements

   12,584    9,242    12,353    8,493 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $30,889   $22,417   $28,777   $20,720 
  

 

 

   

 

 

   

 

 

   

 

 

 

During the first quarter of fiscal 2014, we acquired the remaining licensing rights related to patents that are part of ourillumigene molecular technology for $1,638. These rights are being amortized over a weighted average period of approximately 8.5 years.

   December 31, 2014   September 30, 2014 
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $11,617   $10,626   $11,685   $10,568 

Trademarks, licenses and patents

   6,357    2,870    6,463    2,766 

Customer lists and supply agreements

   12,198    9,517    12,378    9,379 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $30,172   $23,013   $30,526   $22,713 
  

 

 

   

 

 

   

 

 

   

 

 

 

The actual aggregate amortization expense for these intangible assets was $507$469 and $550$526 for the three months ended June 30, 2014 and 2013, respectively, and $1,549 and $1,715 for the nine months ended June 30,December 31, 2014 and 2013, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 20192020 is as follows: remainder of fiscal 2014 – $482, fiscal 2015 – $1,797,$1,233, fiscal 2016 – $1,451,$1,360, fiscal 2017 – $1,177,$1,135, fiscal 2018 – $1,154 and$1,114, fiscal 2019 – $1,113.$1,074 and fiscal 2020 – $898.

 

Page 11


ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Refer to “Forward Looking Statements” following the Table of Contents in front of this Form 10-Q. In the discussion that follows, all dollar amounts are in thousands (both tables and text), except per share data.

Following is a discussion and analysis of the financial statements and other statistical data that management believes will enhance the understanding of Meridian’s financial condition, changes in financial condition and results of operations. This discussion should be read in conjunction with the financial statements and notes thereto beginning on page 1.

Results of Operations

Three Months Ended June 30, 2014

Net earnings for the thirdfirst quarter of fiscal 2014 decreased 13%2015 increased 6% to $8,835,$7,901, or $0.21$0.19 per diluted share, from net earnings for the thirdfirst quarter of fiscal 20132014 of $10,159,$7,426, or $0.24$0.18 per diluted share. This decreaseincrease reflects the combined effects of slightly increased revenues, decreased gross profit marginsmargin percentages and modestly increased operating expenses. Consolidated revenues increased less than 1%7% to $47,212$48,013 for the thirdfirst quarter of fiscal 20142015 compared to the same period of the prior year.year, increasing 8% on a constant-currency basis.

Included within the thirdfirst quarter 2014 resultsof fiscal 2015 were revenues from ourillumigene®molecular platform of products totaling $9,578,$9,908, representing a 9%16% increase over the fiscal 2013 third2014 first quarter. Also contributing to the consolidated revenuerevenues increase were increased revenues in three of ourH. pylori focus product family and our respiratory product family, as well as in our Life Science segment’s molecular component product line. Serving to substantially offset these revenue increases were decreased revenues in our largest diagnostic focus product familyfamilies (C. difficile), our foodborne focus product family and our Life Science segment’s immunoassay component product line.

Page 12


Revenues for the Diagnostics segment for the third quarter of fiscal 2014 decreased less than 1% compared to the third quarter of fiscal 2013, reflecting the following for each of our focus product families: 10% decline in ourC. difficile products, 9% growth in ourH. pylori products,, foodborne and 5% decline in our foodborne products. In addition, we experienced a 9% increase in revenues from our respiratory products, which include both molecularrespiratory) and immunoassay products, compared to the prior year fiscal third quarter. With 6% growth in its molecular component product sales and a 1% decline in its immunoassay component product sales, revenues from our Life Science segment increased by 2% during the third quarter of fiscal 2014 compared to the third quarter of fiscal 2013.

Nine Months Ended June 30, 2014

For the nine month period ended June 30, 2014, net earnings decreased 8% to $26,561, or $0.63 per diluted share, from net earnings for the comparable fiscal 2013 period of $28,882, or $0.69 per diluted share. This decrease reflects the combined effects of increased revenues, decreased gross profit margins and modestly increased operating expenses, along with a $450 (pre-tax) negative effect from medical device tax that did not exist during the first quarter of fiscal 2013 (see discussion in Medical Device Tax below). Consolidated revenues increased 2% to $142,140 for the first nine months of fiscal 2014 compared to the same period of the prior fiscal year.

Included within the nine month year-to-date fiscal 2014 results were revenues from ourillumigene molecular platform of products totaling $27,926, representing a 15% increase over the first nine months of fiscal 2013. Also contributing to the consolidated revenue increase were increased revenues in ourH. pylori focus product family, as well as in both of our Life Science segment’s business lines (i.e., molecular component and immunoassay component). Serving to substantiallypartially offset these revenue increases were decreased revenues in our largest diagnosticC. difficile focus product family (C. difficile) and our respiratory product family.

During the first nine months of fiscal 2014, revenuesRevenues for the Diagnostics segment decreased less than 1% fromfor the comparablefirst quarter of fiscal 2013 period,2015 increased 5% compared to the first quarter of fiscal 2014, increasing 6% on a constant-currency basis and reflecting the following for each of our focus product families: 9% decline5% growth in ourC. difficile foodborne products, 10%12% growth in ourH. pylori products, 31% growth in our respiratory products, and 1%11% decline in our foodborneC. difficile products. In addition, we experienced an 8% decline in revenues fromAs it relates to our respiratory products, from the comparable fiscal 2013 period.growth is substantially driven by our molecular respiratory products (illumigene Group A Strep,illumigene Mycoplasma andillumigene Pertussis products), which were launched into the market over the past two-plus years and represent an ever-increasing percentage of our respiratory product family revenues. With 12% growth in both its molecular component product sales and 6% growth in its immunoassay component product sales,business, revenues fromof our Life Science segment increased by 8%15% during the nine months ended June 30,first quarter of fiscal 2015 compared to the first quarter of fiscal 2014, over the comparable fiscal 2013 period.increasing 16% on a constant-currency basis.

REVENUE OVERVIEW

Below are analyses of the Company’s revenue, provided for each of the following:

- By Reportable Segment & Geographic Region

- By Product Platform/Type

- By Disease Family (Diagnostics only)

Revenue Overview- By Reportable Segment & Geographic Region

Our reportable segments are Diagnostics and Life Science. The Diagnostics segment is headquarteredconsists of manufacturing operations in Cincinnati, Ohio, which also serves asand the basesale and distribution of manufacturing operations and research and development. The Diagnostics segment sells diagnostic test kits in the U.S.countries comprising North, Central and Canada (“North America”South America (the “Americas”); Europe, Middle East and Africa (“EMEA”); and other countries outside of North Americathe Americas and EMEA (rest of the world, or “ROW”). The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents domestically and abroad, including a sales and business development location in Singapore. Additionally, in order to further pursue growing revenue opportunities in Asia, and China in particular, our Life Science segment has opened a business development office in Beijing, China. The Life Science segment also includes the contract development and manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

Page 12


Revenues for the Diagnostics segment, in the normal course of business, may be affected from quarter to quarter by buying patterns of major distributors, seasonality and strength of certain diseases, and foreign currency exchange rates. Revenues for the Life Science segment, in the normal course of business, may be affected from quarter to quarter by the timing and nature of arrangements for contract services work, which may have longer production

Page 13


cycles than bioresearch reagents and bulk antigens and antibodies, as well as buying patterns of major customers, and foreign currency exchange rates. We believe that the overall breadth of our product lines serves to reduce the variability in consolidated revenues.revenues due to these factors.

 

  Three Months Ended June 30, Nine Months Ended June 30,   Three Months Ended December 31, 
  2014 2013 Inc (Dec) 2014 2013 Inc (Dec)   2014 2013 Inc (Dec) 

Diagnostics-

       

North America

  $28,543  $28,307  1 $86,438  $86,003  1

Diagnostics—

    

Americas

  $30,913  $28,261  9

EMEA

   5,464  5,535  (1)%  16,756  16,622  1   5,003  5,373  (7)% 

ROW

   1,161  1,463  (21)%  3,872  4,752  (19)%    670  1,203  (44)% 
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Diagnostics

   35,168   35,305   —    107,066   107,377   —   36,586  34,837  5
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Life Science-

       

North America

   4,749   4,737   —    14,078   13,299   6

Life Science—

Americas

 5,299  4,313  23

EMEA

   5,278   5,124   3  15,287   13,721   11 3,758  3,810  (1)% 

ROW

   2,017   1,942   4  5,709   5,327   7 2,370  1,834  29
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Life Science

   12,044   11,803   2  35,074   32,347   8 11,427  9,957  15
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Consolidated

  $47,212  $47,108   —   $142,140  $139,724   2$48,013 $44,794  7
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

% of total revenues-

       

% of total revenues—

Diagnostics

   74  75   75  77  76 78

Life Science

   26  25   25  23  24 22
  

 

  

 

   

 

  

 

    

 

  

 

  

Total

   100  100   100  100  100 100
  

 

  

 

   

 

  

 

    

 

  

 

  

Ex-North America

   29  30   29  29 

Ex-Americas

 25 27
  

 

  

 

   

 

  

 

    

 

  

 

  

Revenue Overview- By Product Platform/Type

The revenues generated by each of our reportable segments result primarily from the sale of the following segment-specific categories of products:

Diagnostics

 

 1)Molecular tests that operate on ourillumigene platform

 

 2)Immunoassay tests

Life Science

 

 1)Molecular components

 

 2)Immunoassay components

 

Page 1413


RevenueRevenues for each product platform/type, as well as its relative percentage of segment revenue, isare shown below.

 

  Three Months Ended June 30, Nine Months Ended June 30,   Three Months Ended December 31, 
  2014 2013 Inc (Dec) 2014 2013 Inc (Dec)   2014 2013 Inc (Dec) 

Diagnostics-

       

Diagnostics—

    

Molecular

  $9,578  $8,818  9 $27,926  $24,245  15  $9,908  $8,550  16

Immunoassay

   25,590  26,487  (3)%  79,140  83,132  (5)%    26,678  26,287  1
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Diagnostics

  $35,168  $35,305   —   $107,066  $107,377   —  $36,586 $34,837  5
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Life Science-

       

Life Science—

Molecular components

  $5,476  $5,158    $15,369  $13,723   12$5,012 $4,870  3

Immunoassay components

   6,568   6,645   (1)%   19,705   18,624   6 6,415  5,087  26
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

Total Life Science

  $12,044  $11,803    $35,074  $32,347   8$11,427 $9,957  15
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

 

% of Diagnostics revenues-

       

% of Diagnostics revenues—

Molecular

   27  25   26  23  27 25

Immunoassay

   73  75   74  77  73 75
  

 

  

 

   

 

  

 

    

 

  

 

  

Total Diagnostics

   100  100   100  100  100 100
  

 

  

 

   

 

  

 

    

 

  

 

  

% of Life Science revenues-

       

% of Life Science revenues—

Molecular components

   45  44   44  42  44 49

Immunoassay components

   55  56   56  58  56 51
  

 

  

 

   

 

  

 

    

 

  

 

  

Total Life Science

   100  100   100  100  100 100
  

 

  

 

   

 

  

 

    

 

  

 

  

Following is a discussion of the revenues generated by each of these product platforms/types:

Diagnostics Products

illumigene Molecular Platform Products

We have 1,265nearly 1,370 customer account placements. Of these account placements, approximately 1,1301,200 accounts have completed evaluations and validations and are regularly purchasing product, with the balance of our account placements being in some stage of product evaluation and/or validation. Of our account placements, we have approximately 275over 400 accounts that are regularly purchasing, evaluating and/or validating two or more assays. Upon receiving FDA clearance on March 25, 2014, we launched ourBordetella pertussis molecular diagnostic test in early April – the most recent test available on ourillumigene molecular testing platform.

We continue to invest in new product development for our molecular testing platform,illumigene molecular testing. This platform and with the launch of theBordetella pertussis test, now havehas five commercialized tests, on the platform andwith three additional tests expected to be available for sale in fiscal 2015:

 

 1.illumigene® C. difficile – commercialized in August 2010

 2.illumigene® Group BStreptococcus (Group B Strep or GBS) – commercialized in December 2011

 3.illumigene® Group AStreptococcus (Group A Strep) – commercialized in September 2012

 4.illumigene® Mycoplasma (M. pneumonia; walking pneumonia) – commercialized in June 2013

 5.illumigene®Bordetella pertussis (whooping cough) – commercialized in March 2014

 6.illumigene®Chlamydia trachomatis – expected fiscal 2015 (launch outside of U.S.)

 7.illumigene®Neisseria gonorrhea – expected fiscal 2015 (launch outside of U.S.)

 8.illumigene® Herpes Simplex Virus I & II – expected fiscal 2015

Additionalillumigene tests in early-stage research and development include enteric parasites such as Giardia, foodborne pathogens such asE. coliCampylobacter jejuni, and bloodborne pathogens such as the causative agents for malaria.

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We believe that the diagnostic testing market is continuing to move away from culture and immunoassay testing to molecular testing for diseases where there is a favorable cost/benefit position for the total cost of healthcare.health care. While this market is competitive, with molecular companies such as Cepheid and Becton Dickinson and new more recent

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entrants such as Quidel, Great Basin, Nanosphere, and others, we believe we are well positioned to capitalize on the migration to molecular testing. Our simple, easy-to-use,illumigene platform, with its expanding menu, requires no expensive equipment purchase and little to no maintenance cost. TheseWe believe these features, along with its small footprint and the performance of theillumigene assays, makeillumigene an attractive molecular platform to any size hospital or physician office laboratory.

Immunoassay Products

Revenues from our Diagnostics segment’s immunoassay products decreased 3%increased 1% in the thirdfirst quarter of fiscal 2014 and decreased 5% on a nine month, year-to-date basis.2015. As described in the product discussionsdiscussion below, the quarterly decreasethis minimal revenue growth results primarily from the growth in our foodborne andH. pylori products, substantially offset by the decline in revenues from ourC. difficilethe immunoassay products partially offset by the revenue growth of ourH. pylori and respiratory products; while the year-to-date decrease results primarily from the decline in revenues fromwithin ourC. difficile and respiratory products, partially offset by the revenue growth of ourH. pylori products.product families.

Life Science Products

During the thirdfirst quarter of fiscal 2014,2015, revenues from our Life Science segment increased 2%15%, with revenues from molecular component sales and immunoassay component sales increasing 6%3% and 26%, respectively, over the comparable fiscal 2013 quarter and revenues from immunoassay component sales decreasing 1%. For the first nine months of fiscal 2014 revenues from our Life Science segment increased 8%, with revenues from molecular component sales increasing 12% over the comparable prior year period and revenues from immunoassay component sales increasing 6%.quarter. Our molecular component revenues continue to benefit from new product launchesbusiness’ growth was negatively impacted by the movement in currency exchange rates since the 2014 first quarter and advancements – most notably SensiFAST™ and MyTaq™ PCR components.the ordering patterns of industrial customers, as such customers become an increasing percentage of the molecular component business; while our immunoassay component business experienced in excess of a 150% increase in sales into China.

DiagnosticDiagnostics Revenue Overview- By Disease Family

Revenues from our focus families (C. difficile, foodborne, andH. pylori) and respiratory) comprised 63%74% and 73% of our Diagnostics segment’s revenuerevenues during the thirdfirst quarter of fiscal 20142015 and 61% during the first nine months of the fiscal year. This compared to 65% and 61% during the fiscal 2013 quarterly and year-to-date periods,2014, respectively. Following is a discussion of the revenues generated by each product family:

C. difficile Products

RevenuesDuring the fiscal 2015 first quarter, revenues for ourC. difficile product family decreased 10%11% to $8,900 for$7,600 from the first quarter of fiscal 2014, third quarter, and decreased 9%as this market continues to $26,800 for the nine month, year-to-date period. Revenues for ourillumigene product decreased 5% and 1% during the three and nine month periods ended June 30, 2014, respectively, and revenues for ourC. difficile immunoassay products continued to significantly decline as expected. TheC. difficile market has become highlybe competitive, with over 10 suppliers in the United States. Certain of these suppliers choose to compete solely on price. We believe that two factors will help us respond to these challenging market conditions. First, our marketing programs emphasize that we are the only company that can offer a full range of high performing, FDA cleared,C. difficile testing formats, including toxin, GDH and molecular tests. Second, ourillumigene molecular platform, with its expanding menu, requires no expensive equipment purchase or maintenance contract, which we believe makes it an attractive and affordable option for any size hospital.

Foodborne Products

Revenues forfrom our foodborne products (EnterohemorrhagicE. coli(“EHEC”)(EHEC) andCampylobacter), all of which are immunoassay products, totaled $5,800$6,000 during the first quarter of fiscal 2015, a 5% increase from the fiscal 2014 third quarter, a 5% decrease from the fiscal 2013 thirdfirst quarter. During the nine months ended June 30, 2014, foodborne revenues totaled $16,900, a 1% decrease from the fiscal 2013 year-to-date period. We are once again disappointed in the results for this product family and are continuing to re-emphasize the benefits of increased sensitivity and faster turnaround time versus culture methods in our marketing programs. While historically theThe primary competition for our foodborne products has beenis laboratory culture methods during 2012and an immunoassay shiga toxin test from one of our competitors cleared through the FDA a shiga toxin test that competes with our EHEC test.competitors. We believe that our test offers better workflow, less hands-on time and quicker results, in addition to being fully CDC-compliant.compliant with CDC-recommended testing methods.

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H. pylori Products

During the thirdfiscal 2015 first quarter, of fiscal 2014, revenues from ourH. pylori products, all of which are immunoassay products, increased 9%12% to $7,400; and increased 10% to $21,000 during the first nine months of fiscal 2014. These increases continue$7,300. This increase continues to reflect the benefits of our partnerships with managed care companies in promoting the health and economic benefits of a test and treat strategy, and the ongoing effects of such strategy moving physician behavior away from serology-based testing toward direct antigen testing. A significant amount of theH. pylori product revenues are from sales to reference labs, whose buying patterns may not be consistent period to period.

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Respiratory Products

Total respiratory revenues fromfor our Diagnostics segment increased 9%31% to $3,700$6,200 during the first quarter of fiscal 2014 third quarter; and decreased 8% to $13,800 for the nine month year-to-date period. Contributing to the quarterly increase was growth in our2015. Our molecular respiratory products (illumigene Group A Strep,illumigene Mycoplasma andillumigene Pertussis products. Lowerproducts), which were launched into the market over the past two-plus years, experienced in excess of 200% growth during the first quarter of fiscal 2015. Serving to partially offset this increase was a 6% decline in our immunoassay respiratory products, reflecting the decline in revenues from sales of influenzasuch products contributedin Japan due to the year-to-date decline in revenue. Partially offsetting the impact of lower influenza product revenues was growth in the aforementioned respiratory-relatedillumigene products.continuing issues related to our Japanese distributor having been acquired last year.

Foreign Currency

During the thirdfirst quarter of fiscal 2014,2015, currency exchange rates had a $350 favorable$600 unfavorable impact on revenue; $200 favorablerevenues; $400 within the Diagnostics segment and $150 favorable in the Life Science segment. On a nine month year-to-date basis, currency exchange rates had a $700 favorable impact on revenue; $600 favorable$200 within the Diagnostics segment and $100 favorable in the Life Science segment.

Significant Customers

Two U.S. distributors accounted for 36%41% and 40%38% of our Diagnostics segment’s total revenues for the thirdfirst quarter of fiscal 20142015 and 2013, respectively, and 36% and 43% during the nine months ended June 30, 2014, and 2013, respectively. These customersrevenues represented 26%31% and 30%29% of consolidated revenues for the fiscal 2015 and 2014 and 2013 thirdfirst quarters, respectively, and 27% and 33% for the respective year-to-date nine month periods.respectively.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 15%18% and 18%10% of the segment’s total revenues for the thirdfirst quarter of fiscal 20142015 and 2013, respectively, and 16% and 18% during the nine months ended June 30, 2014, and 2013, respectively.

Medical Device Tax

On January 1, 2013, the medical device tax established as part of the U.S. healthcarehealth care reform legislation became effective, and as a result, the Company made its first required tax deposit near the end of January 2013. TheDuring the first quarter of fiscal 2015 and fiscal 2014, the Company recorded approximately $450$500 and $400, respectively, of medical device tax expense, during each of the fiscal 2014 and 2013 third quarters, which is reflected as a component of cost of sales in the accompanying Condensed Consolidated Statements of Operations. During the nine month periods ended June 30, 2014 and 2013, medical device tax expense totaling approximately $1,350 and $900, respectively, was recorded.

Gross Profit

 

   Three Months Ended June 30,  Nine Months Ended June 30, 
   2014  2013  Change  2014  2013  Change 

Gross Profit

  $29,242  $30,631    (5)%  $88,842  $90,170    (1)% 

Gross Profit Margin

   62  65  -3 points    63  65  -2 points  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

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   Three Months Ended December 31, 
   2014  2013  Change 

Gross Profit

  $29,237  $28,007   4

Gross Profit Margin

   61  63  -2 points  

The overall gross profit margin decrease for the three and nine months ended June 30,December 31, 2014 primarily results from the combined effects of (i) mix of revenues from the Company’s segments; (ii) mix of products sold; and (iii) declines in pricing on selected products; (iv)unfavorable manufacturing facility utilization;overhead absorption. Due to our growingillumigene platform, we have invested approximately $4,000 in new molecular manufacturing facilities, which will provide additional manufacturing capacity, as well as improved manufacturing efficiency and for the nine month period only (v) the medical device tax, which did not exist during the first quarter ofquality. We believe that we will begin to realize these efficiencies late in fiscal 2013 (see discussion in Medical Device Tax above).2015.

Our overall operations consist of the sale of diagnostic test kits for various disease states and in alternative test formats, as well as bioresearch reagents, bulk antigens and antibodies, PCR/qPCR reagents, nucleotides, competent cells, proficiency panels, and contract research and development, and contract manufacturing services. Product revenue mix shifts, in the normal course of business, can cause the consolidated gross profit margin to fluctuate by several points.

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Operating Expenses

 

  Three Months Ended June 30, 2014   
  Research &
Development
 Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
   Changes for the
Three Months Ended December 31, 2014
 

2013 Expenses

  $2,711  $5,440  $6,781  $14,932 
  

 

  

 

  

 

  

 

 

% of Revenues

   6  12  14  32

Fiscal 2014 Increases (Decreases):

     

Diagnostics

   419   446   93   958 

Life Science

   16   363   (159  220 
  

 

  

 

  

 

  

 

   Research &
Development
 Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
 

2014 Expenses

  $3,146  $6,249  $6,715  $16,110   $2,853  $5,978  $7,550  $16,381 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

% of Revenues

   7  13  14  34 6 13 17 37

% Increase (Decrease)

   16  15  (1)%   8
  Nine Months Ended June 30, 2014 
  Research &
Development
 Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
 

2013 Expenses

  $8,039  $16,604  $21,484  $46,127 
  

 

  

 

  

 

  

 

 

% of Revenues

   6  12  15  33

Fiscal 2014 Increases (Decreases):

     

Fiscal 2015 Increases (Decreases):

Diagnostics

   1,134   1,329   (370  2,093  181  120  15  316 

Life Science

   12   854   (668  198  69  (18 (180 (129
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

2014 Expenses

  $9,185  $18,787  $20,446  $48,418 

2015 Expenses

$3,103 $6,080 $7,385 $16,568 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

% of Revenues

   6  13  14  34 6 13 15 35

% Increase (Decrease)

   14  13  (5)%   5 9 2 (2)%  1

Overall, total operating expenses increased slightly during both the thirdfirst quarter and first nine months of fiscal 20142015 relative to the comparable prior fiscal year periods, increasingquarter, while decreasing slightly as a percentage of quarterly and year-to-date consolidated revenues. These levels of operating expenses resultThe increase results in large part from the combined effects of our (i) ongoing efforts to control spending in each of our segments while investing the necessary resources in our strategic areas of growth, including increased investment in Research & Development for our molecular platform products;products and increased investment in Sales and Marketing personnel and programs; and (ii) overall decreasedincreased incentive compensation expense in light of the decline in corporate-wide operating profits.profit levels.

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Operating expenses for the Diagnostics segment increased $958$316 for the thirdfirst quarter of fiscal 20142015 compared to the fiscal 2013 third quarter, and in the2014 first nine months of fiscal 2014, increased $2,093 over the comparable prior year period.quarter. These overall increases result largely from the combined effects of (i) currency exchange rates (increases of $100 and $200 for the quarter and year-to-date, respectively); and (ii) the following:

Research & Development

Overall increase in spending on new product development activities, related primarily to the previously noted products for ourillumigene molecular platform, as well as immunoassay products in development.

Selling & Marketing

Addition of fieldIncreased sales force personnel, including the filling of open territorial positions, since the prior year quarter, resulting in an approximate $300 increase in personnel-relatedcommission expenses on a quarterly basis ($900 on a year-to-date basis), along with increased product sample expense of approximately $100 for the quarter ($250 year-to-date).revenues.

General & Administrative

A decreaseAn increase in bonus and profit sharing expense as a result of the previously noted declineyear-to-date increase in corporate-wide operating profits, partiallysubstantially offset by an approximate $100 and $700 increasea decrease in stock-based compensation during the third quarter and first nine months of fiscal 2014, respectively, and other less significant general operating expense increases.

Operating expenses for the Life Science segment increased $220 and $198 for the third quarter and first nine months of fiscal 2014, respectively. This activity reflectsresulting in large part the net effects of (i) currency exchange rates (increases of $100 and $50 for the quarter and year-to-date, respectively); (ii) ongoing increased sales and marketing investments; and (iii) decreased bonus expenses resulting from the decline in corporate-wide operating profits.our stock price relative to the fiscal 2014 first quarter.

Operating Income

Operating income decreased 16%increased 9% to $13,132$12,669 for the thirdfirst quarter of fiscal 2014, and decreased 8% to $40,424 for the first nine months of fiscal 2014,2015, as a result of the factors discussed above.

Income Taxes

The effective rate for income taxes was 31% andremained stable at 35% for the third quarterfirst quarters of fiscal 20142015 and 2013, respectively, and 33% and 35% for the nine month, year-to-date periods ended June 30, 2014 and 2013, respectively. The lower current year rates primarily result from the positive effects of research credits in certain foreign jurisdictions and a net U.S. foreign tax credit resulting from a recent restructuring of our legal entities.fiscal 2014. For the fiscal year ending September 30, 2014,2015, we expect the effective tax rate to approximate 34%-35%.

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In September 2013, the Internal Revenue Service issued Treasury Decision 9636, which enacted final tax regulations regarding the capitalization and expensing of amounts paid to acquire, produce, or improve tangible property. The regulations also include guidance regarding the retirement of depreciable property. The regulations are required to be effective in taxable years beginning on or after January 1, 2014, although taxpayers may choose to apply them in taxable years beginning on or after January 1, 2012. Our adoption of these regulations on October 1, 2014 isdid not expected to have a significant impact on the Company’s consolidated results of operations, cash flows or financial position.

Liquidity and Capital Resources

Comparative Cash Flow Analysis

Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets, consideration of acquisition plans, and consideration of common share dividends. We have historically maintained a credit facility to augment working capital requirements and to respond quickly to acquisition opportunities. Our investment portfolio presently consists of overnight repurchase agreements.

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We have an investment policy that guides the holdings of our investment portfolio. Our objectives in managing the investment portfolio are to (i) preserve capital; (ii) provide sufficient liquidity to meet working capital requirements and fund strategic objectives such as acquisitions; and (iii) capture a market rate of return commensurate with market conditions and our policy’s investment eligibility criteria. As we look forward, we will continue to manage the holdings of our investment portfolio with preservation of capital being the primary objective.

We do not expect current conditions in the financial markets, or overall economic conditions, to have a significant impact on our liquidity needs, financial condition, or results of operations, although no assurances can be made in this regard. We intend to continue to fund our working capital requirements and dividends from current cash flows from operating activities and cash on hand. If needed, we also have an additional source of liquidity through our $30,000 bank credit facility. Approximately $3,400$2,100 of our consolidated accounts receivable at June 30,December 31, 2014 is due from Italian hospital customers whose funding ultimately comes from the Italian government, which is down from approximately $3,500 due on such accounts$2,700 at September 30, 2013.2014. Our liquidity needs may change if overall economic conditions changeworsen and/or liquidity and credit within the financial markets tightens for an extended period of time, and such conditions impact the collectibility of our customer accounts receivable or impact credit terms with our vendors, or disrupt the supply of raw materials and services.

Net cash provided by operating activities decreased 27%increased 72% for the first nine monthsquarter of fiscal 20142015 to $23,611,$16,085, reflecting the 8% decrease6% increase in net earnings, along with the effects of the payment of incentive bonus payments related to fiscal 2013 made in the first quarter of fiscal 2014, the timing of federal income tax payments, inventory purchases, and the timing of payments from and to customers and suppliers, respectively. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements, capital expenditures and dividends during the next 12 months.

Capital Resources

We have a $30,000 credit facility with a commercial bank that expires on September 15, 2015. As of JulyJanuary 31, 2014,2015, there were no borrowings outstanding on this facility and we had 100% borrowing capacity available to us. We have had no borrowings outstanding under this facility during the first ninethree months of fiscal 20142015 or during the full year of fiscal 2013.2014.

Our capital expenditures are estimated to range betweenbe approximately $5,000 to $6,000$4,000 for fiscal 2014,2015, with the actual amount depending upon actual operating results and the phasing of certain projects. Such expenditures may be funded with cash and equivalents on hand, operating cash flows, and/or availability under the $30,000 credit facility discussed above. This range of capital expenditures includes approximately $4,000 related to an expansion of our molecular diagnostic manufacturing capacity in Cincinnati, Ohio.

We do not utilize any special-purpose financing vehicles or have any undisclosed off-balance sheet arrangements.

Recent Accounting Pronouncements

In May 2014, FASB issued ASU No. 2014-09,Revenue from Contracts with Customers, which supersedes and replaces nearly all currently-existing U.S. GAAP revenue recognition guidance including related disclosure requirements. This guidance will be effective for the Company beginning October 1, 2017. The Company has not yet assessed the impact that adoption of this guidance will have on its financial statements.

 

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ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in the Company’s exposure to market risk since September 30, 2013.2014.

ITEM 4.CONTROLS AND PROCEDURES

ITEM 4. CONTROLS AND PROCEDURES

As of June 30,December 31, 2014, an evaluation was completed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of June 30,December 31, 2014. There have been no changes in our internal control over financial reporting identified in connection with the evaluation of internal control that occurred during the thirdfirst fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting, or in other factors that could materially affect internal control subsequent to June  30,December 31, 2014.

PART II. OTHER INFORMATION

ITEM 1A.RISK FACTORS

ITEM 1A. RISK FACTORS

There have been no material changes from risk factors as previously disclosed in the Registrant’s Form 10-K in response to Item 1A to Part I of Form 10-K.

ITEM 6.EXHIBITS

ITEM 6. EXHIBITS

The following exhibits are being filed or furnished as a part of this Quarterly Report on Form 10-Q.

 

10.1Second Amended and Restated Agreement Concerning Disability and Death effective as of June 19, 2014 by and between Meridian Bioscience, Inc., Fifth Third Bank, Trustee of the Motto Family Irrevocable Wealth Accumulation Trust Agreement dated September 22, 2006, and William J. Motto

31.1Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)

31.2Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)

32Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101The following financial information from Meridian Bioscience Inc.’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2014 filed with the SEC on February 9, 2015, formatted in XBRL includes: (i) Condensed Consolidated Statements of Operations for the three months ended December 31, 2014 and 2013; (ii) Condensed Consolidated Statements of Comprehensive Income for the three months ended December 31, 2014 and 2013; (iii) Condensed Consolidated Statements of Cash Flows for the three months ended December 31, 2014 and 2013; (iv) Condensed Consolidated Balance Sheets as of December 31, 2014 and September 30, 2014; (v) Condensed Consolidated Statement of Shareholders’ Equity for the three months ended December 31, 2014; and (vi) the Notes to Condensed Consolidated Financial Statements

 

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  MERIDIAN BIOSCIENCE, INC.
Date:August 11, 2014 February 9, 2015  By: 

/s/ Melissa A. Lueke

   Melissa A. Lueke
   

Executive Vice President and

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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